A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers

This study has been completed.

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00000847

First Posted: August 31, 2001

Last Update Posted: March 17, 2014

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To evaluate the safety and immunogenicity of high-titered ALVAC-HIV MN120TMG (vCP205) given sequentially or simultaneously with rgp120/HIV-1SF2 in MF59 adjuvant emulsion in HIV-negative volunteers.

ALVAC-HIV vCP205 is a second-generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens. vCP205 expresses proteins from two strains of HIV (MN and LAI). rgp120/HIV-1SF2 expresses proteins from a different strain of HIV. This study will help to show how the immune system responds to proteins from more than one strain of virus.

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

150

Study Completion Date:

May 1999

Detailed Description:

ALVAC-HIV vCP205 is a second-generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens. vCP205 expresses proteins from two strains of HIV (MN and LAI). rgp120/HIV-1SF2 expresses proteins from a different strain of HIV. This study will help to show how the immune system responds to proteins from more than one strain of virus.

Six groups of 25 volunteers each are randomized to receive simultaneous or sequential doses of ALVAC-HIV vCP205 and SF2 rgp120 or control vaccines (ALVAC-RG rabies glycoprotein vCP65 or BIOCINE Placebo Vaccine 2). In each group, 21 volunteers receive vaccine and 4 receive control vaccines. Volunteers are stratified by lower or higher risk sexual behavior. Immunizations are given to three groups at months 0, 1, 3, 6, 9, and 12, and to the other three groups at months 0, 1, 6, 9, and 12. Volunteers are followed for 24 months.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 60 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria

Volunteers must have:

Normal history and physical exam.

Negative ELISA and Western blot for HIV.

CD4 count >= 400 cells/mm3.

Normal urine dipstick with esterase and nitrite.

NOTE:

No more than 10 percent of volunteers in each stratum may be over age 50.